EMBLEM™ MRI S-ICD System
Subcutaneous Implantable Defibrillator
The Only Device of its Kind
The S-ICD system was designed to address the main complications that may occur in Transvenous ICDs: Lead Complications and Infection.1
More than 18 years of clinical data shows that the S-ICD is safe and effective and has comparable performance to TV-ICD in treating VT/VF.2,3
The S-ICD System leaves the heart and vasculature UNTOUCHED, avoiding the complications associated with transvenous leads.
Product Details
The EMBLEM MRI S-ICD system provides effective defibrillation without transvenous leads, offering a less invasive solution for patients at risk of sudden cardiac arrest.
- Eliminates potential for vascular injury.
- Preserves venous access.
- Reduces potential for systemic infection.
- Remains outside the sternum, never touching the heart.
The innovation in S-ICD technology and implant technique has significantly improved over the last 18 years. The proven S-ICD system has been implanted in over 99,000+ patients Worldwide and has valuable clinical evidence of long-term efficacy, demonstrating consistently high spontaneous shock efficacy over an average of 5 years of follow-up – results that are not only comparable to, but better than results demonstrated in many TV-ICD studies.3-12
S-ICD is Recommended in both US and EU Guidelines
| Guidance | 2017 AHA/ACC/HRS Guidelines13 | 2015 ESC Guidelines | For S-ICD patients... |
|---|---|---|---|
| Class I |  |
With high risk of infection, including Diabetic patients (up to 35% of the ICS population)14 | |
| Class IIa | |
|
Without need of pacing (CRT, bradycardia, ATP) |
The 2017 Guidelines by the American Heart Association (AHA), American College of Cardiology (ACC), and the Heart Rhythm Society (HRS) include recommended use of the S-ICD for ICD indicated patients with:
High Infection Risk
~75% of ICD Indicated Patients with ≥1 Comorbidities Associated with Device Infection.15,16,17
Inadequate Venous Access
No Pacing Indication
% of VR and DR ICD Patients Under 75 with No Pacing Indication at Implant.
TV-ICD Lead Complications in the Real World
The transvenous lead is the most common source of complications in a TV-ICD system. Data from over 40,000 patients from the OptumLabs Data Warehouse demonstrated that the incidence of mechanical and infectious complications of transvenous leads over long-term follow-up is much higher in the real world than in clinical studies.
